Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000677303
Ethics application status
Approved
Date submitted
28/04/2017
Date registered
12/05/2017
Date last updated
12/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Compassion at the heart of well-being: an inter-disciplinary study to evaluate the effect of a meditation intervention and a positive psychology intervention on well-being and compassionate care among healthcare employees
Scientific title
Compassion at the heart of well-being: an inter-disciplinary study to evaluate the effect of a meditation intervention and a positive psychology intervention on well-being and compassionate care among healthcare employees
Secondary ID [1] 291480 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
nurse well-being 302768 0
nurse compassionate care 302769 0
Condition category
Condition code
Mental Health 302283 302283 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Meditation intervention
- The training will involve 3 x 6-hour workshops in a group setting. Training will combine psycho-education and instruction; participant experiential exercises (ie, meditative exercises), self-reflection, peer-to-peer discussion and review, and whole-of-group discussion and review.
- The meditation exercises are: deep relaxation meditation ("yoga-nidra" practice); mindful breathing and body-awareness; loving-kindness meditation; other-oriented compassion meditation; and self-compassion meditation.
- Participants will receive worksheets to complete reflective exercises and take notes during the training sessions
- This intervention will be delivered by an experienced meditation trainer with over 10 years teaching experience.
- This intervention will be delivered face to face in a group
- The intervention will comprise 3 x 6-hour workshops over 4 weeks (session 1 will be in week 0 of the trial; session 2 will be in week 2 of the trial and session 3 will be in week 4 of the trial).
- The intervention will occur in metropolitan hospitals and health-care centres (i.e., the workplace of participant nurses)
- Adherence to the intervention protocol will be monitored via a third-party research assistant with experience in participating in meditation programs, sitting in on approximately 20% of training sessions across the trial.

Arm 2: Positive psychology intervention
- The training will involve 3 x 6-hour workshops in a group setting. Training will combine psycho-education and instruction; participant experiential exercises (ie, positive psychology and self-coaching exercises), self-reflection, peer-to-peer discussion and review, and whole-of-group discussion and review.
- The experiential activities in this intervention focus on the development of skills relating to: values-clarification, strengths-identification and goal-setting; solutions-focused thinking and self-coaching; developing self-kindness (non-meditative), gratitude and connecting to others.
- Participants will receive worksheets to complete reflective exercises and take notes during the training sessions
- This intervention will be delivered by an experienced coach and positive psychology trainer with over 10 years teaching experience.
- Mode of delivery: This intervention will be delivered face to face in a group;
- The intervention will comprise 3 x 6-hour workshops over 4 weeks (session 1 will be in week 0 of the trial; session 2 will be in week 2 of the trial and session 3 will be in week 4 of the trial).
- The intervention will occur in metropolitan hospitals (i.e., the workplace of participant nurses)
- Adherence to the intervention protocol will be monitored via a third-party research assistant with experience in participating in positive psychology programs, sitting in on approximately 20% of training sessions across the trial.
Intervention code [1] 297719 0
Behaviour
Intervention code [2] 297720 0
Lifestyle
Comparator / control treatment
Waitlist control condition
- Participants allocated to this condition will complete survey measures at the same time as the treatment conditions, but have no other contact with this research until after the follow-up survey has been administered, at which point they will receive one of the two treatment interventions.
- Participants will be able to choose which of these two interventions they participate in.
- Waitlist study participants will complete their chosen intervention at or after 16 weeks from the commencement of the active arms of the study.
Control group
Active

Outcomes
Primary outcome [1] 301690 0
Primary Outcome 1: General well-being as measured by the Warwick-Edinburgh Mental Well-being Scale
Timepoint [1] 301690 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Primary outcome [2] 301691 0
Primary Outcome 2: Compassionate nursing care, measured using the Compassionate Care Scale (Fairbrother et al, under review)
Timepoint [2] 301691 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Primary outcome [3] 301692 0
Primary Outcome 3: Motivation for and enactment of compassionate behaviours as measured by the Compassion Motivation and Action Scale (Steindl, Kirby, Tellegen, Filus, Seppala, and Doty, 2017)
Timepoint [3] 301692 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [1] 333572 0
Self-compassion as measured by the Short Self-Compassion Scale Raes et al., 2011)
Timepoint [1] 333572 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [2] 333713 0
Empathy and perspective-taking measured using the Interpersonal Reactivity Index (Davis, 1987)
Timepoint [2] 333713 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [3] 333714 0
Behavioural empathy measured by the Reading the Mind in the Eyes Test (Vellante, M., et al., 2012).
Timepoint [3] 333714 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [4] 333715 0
Mindfulness measured using the Five Facets of Mindfulness (Short-Form) Scale (Bohlmeijer et al., 2011)
Timepoint [4] 333715 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [5] 333716 0
Experiential avoidance measured using the Brief Experiential Avoidance Questionnaire (Sahdra et al, 2016)
Timepoint [5] 333716 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [6] 333717 0
Life satisfaction measured using the European Social Survey (2013)
Timepoint [6] 333717 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [7] 333718 0
Meaningfulness of work measured by a single item from Fairbrother, Jones and Rivas (2009)
Timepoint [7] 333718 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [8] 333719 0
Psychological safety measured using a measure of the construct from Edmondson (1999).
Timepoint [8] 333719 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [9] 333720 0
Climate of compassion adapted from the Psychological Safety Scale of Edmondson (1999)
Timepoint [9] 333720 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [10] 333722 0
Burnout measured using a two-item measure validated by West, C. P., et al. (2009)
Timepoint [10] 333722 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [11] 333723 0
Perceived stress, measured using the 4-item version of the perceived stress scale (Cohen, Kamarck, & Mermelstein, 1983).
Timepoint [11] 333723 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [12] 333724 0
Solutions-focused thinking using the Solutions-Focused Inventory (Grant, et al., 2012).
Timepoint [12] 333724 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [13] 333725 0
Prosocial behaviour at work, measured using the 'helping' subscale of the organisational citizenship behaviour scale of of Podsakoff et al (1997).
Timepoint [13] 333725 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [14] 333726 0
Job satisfaction using a single-item measure from Judge et al (1994).
Timepoint [14] 333726 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [15] 334264 0
Job engagement as measured by the job engagement scale (Rich, LePine, & Crawford, 2010).
Timepoint [15] 334264 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [16] 334532 0
Social Network Analysis: Intervention participants will be asked to nominate between 5 – 10 individuals in their workplace network who are important for the work that they do. They will then be asked the following questions, referring to the quality and frequency of their interaction and compassion-based experience regarding their perception of each of the nominated individuals:

1. Communication - Please rate the relative frequency of communication you have with this individual

2. To what extent do you perceive this person to be energising in your interactions with them?

3. To what extent has this person shown compassion towards you?

4. To what extent do you perceive this person to be willing to show compassion towards staff?

5. To what extent do you perceive this person to be willing to show compassionate towards patients and their families?
Timepoint [16] 334532 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [17] 334536 0
State energy (a dyadic measure): Imagine that your mental, emotional, and physical energy at work is like having 3 different types of petrol tanks. At this moment, how full is your….?
1. MENTAL energy tank
2. EMOTIONAL energy tank
3. PHYSICAL energy tank
(0% - 100%)
Timepoint [17] 334536 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [18] 334538 0
Nurse / midwife assessments of their own compassionate care in relation to a small number of patients on a given day (a dyadic measure): During your interaction with your patient, to what extent did you:
1. give your full attention to the patient
2. feel warmth towards the patient
3. believe that the patient deserved compassion
4. see this patient as having a lot in common with you
5. imagine how you would feel in their situation
6. express care and compassion through your words and actions
7. feel confident managing their emotional needs
8. manage your own emotions effectively
Timepoint [18] 334538 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [19] 334540 0
Patient state affect (a dyadic measure): At this moment how do you feel?
Timepoint [19] 334540 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [20] 334542 0
Patient assessment of nurse compassionate care a dyadic measure): During your interaction with the nurse/midwife, to what extent did you feel
1. they gave you their full attention
2. they focused on your feelings (as well as your medical needs)
3. confident in the care you received
4. able to talk about your feelings or worries
5. felt genuinely listened to
6. your nurse was warm
7. your nurse was caring and compassionate
Timepoint [20] 334542 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [21] 334545 0
State affect (a dyadic measure): At this moment, to what extent do you feel:
1. Enthusiastic
2. Calm
3. Distressed
4. Angry
5. Sad
Timepoint [21] 334545 0
Timepoint: Baseline, and at 4 and 16 weeks after intervention
commencement
Secondary outcome [22] 334550 0
Nurse and midwife responses to ethnographic interviews: This specifically ethnographic approach will seek to explore the ‘life of a nurse’ at depth using an unstructured interview approach. The main purpose of this material is to inform the research group’s overall analysis of the impact of the intervention, and to raise issues that might not be covered directly by other more formally specified measures
Timepoint [22] 334550 0
Timepoint: There will be one interview administered pre-intervention and one administered post-intervention, for each interview participant.
Secondary outcome [23] 334551 0
Ethnographic observation: We expect to also conduct a limited amount of on-ward observation using a trained ethnographer. Our aim is to record and understand the physical processes of work and the hierarchical structure of control within the ward: what gets done, at what times, under what time pressures, the physical structure of the ward, how much flexibility nurses have in what they do and how that gets interpreted and used), and how these might affect the nurses' motivation and the patients' experience of their interaction with the nurses. What kind of spaces do the nurses have to relax, take a break, socialise with each other? Are there religious facilities provided, if so what are they? Are there any obvious sources of tension and conflict?
Timepoint [23] 334551 0
Both pre- and post- the interventions (the ethnographic observation is aimed at understanding how the ward or unit works rather than observing the specific people in the study)
Secondary outcome [24] 334552 0
General Semi-structured Interviews regarding compassion and wellbeing:

These will be interviews conducted with 20 nurse/midwives (10 from each of the active arms of the study). Sample Interview Questions for semi-structured interviews at baseline:

COMPASSION
Q area: Can you speak about your understanding of compassion?
What does this mean for you?
How has this changed in the course of your career?
Can you give me an example of you at your most compassionate?
Q area: Thinking about your clinical work in particular, can you speak about your understanding of compassionate care?
What is compassionate care for you? Can you give me an example?
How would you identify compassionate care in the context of your own practice?
How would you identify it in the context of your colleagues’ practice?
Q area: Can you describe a time when you felt as though you were less compassionate than you wished to be towards a patient? What happened? What gets in the way of compassion towards patients? Do you feel that there are some kinds of patients who are less deserving of compassion?
Q area: How compassionate are you expected to be towards your patients? From which directions do you sense such expectations?
Q area: Do you find that you exercise compassion more often in your work life than in your personal life? Or is it the other way round?
Q area: How compassionate are you to yourself?

WELLBEING
Q area: Can you speak about your understanding of well-being? Can you describe a time when you experienced a sense of well-being? What did you notice? What are the things in your life that are most important for your well-being? How does your own well-being impact on your work life? Your personal life? How is well-being maintained and developed for you?
Q area: How is well-being related to compassion for you? Can you give an example?
Q area: timeline. Can you draw for me a timeline of your career as a nurse/midwife, and then plots times when you felt most and least well-being. What were the key events and changes that led to these changes in well-being? What have you learned about how best to maintain your own well-being?
Timepoint [24] 334552 0
Pre-intervention
Secondary outcome [25] 334554 0
Sample Interview Questions for semi-structured interviews post-intervention:
Questions for Arm 1:
Q area: What were your expectations before you started your involvement in the program?
Q area: Can you talk about your prior knowledge/experience of meditation?
Q area: What were your experiences when you first began the sessions?
Q area: What were your experiences as you progressed through the sessions?
Q area: Did anything change as time went on? If so, what did you notice?
Q area: Did you meditate in between sessions? If you did, how often? How did you manage to do that?
Q area: Can you describe things you have learned as a result of being involved in the program?
Q area: Have you noticed any changes in your behaviours or everyday thoughts following commencement?
Q area: Have you noticed any changes to your approach to work, or to your life in general ?
Can you speak about any changes you’ve noticed in relation to your relationships with the patients you work with?

Questions for the Arm 2:
Q area: What were your expectations before you started your involvement in the program?
Q area: Can you talk about your prior knowledge/experience of well-being?
Q area: What were your experiences when you first began the sessions?
Q area: What were your experiences as you progressed through the sessions?
Q area: Did anything change as time went on? If so, what did you notice?
Q area: Can you describe things you have learned as a result of being involved in the program?
Q area: Have you noticed any changes in your behaviours or everyday thoughts following commencement?
Q area: Have you noticed any changes to your approach to work, or to your life in general ?
Can you speak about any changes you’ve noticed in relation to your relationships with the patients you work with?
Timepoint [25] 334554 0
Post-intervention (4 weeks after intervention commencement)
Secondary outcome [26] 334555 0
Interview Questions for semi-structured interviews at four month follow up

Questions for the Arm 1:

The four month follow up interviews will differ in some aspects for the two groups under study. The groups will be interviewed the context of the interventions they have received.

Q area: In the baseline interview, we discussed your understanding and experience of compassion. Can you speak about any changes you’ve noticed in the last 4 months regarding how you understand and experience compassion? At work? In your personal life?
Q area: In the baseline interview, we also discussed your understanding and experience of well-being. Can you speak about any changes you’ve noticed in the last 4 months regarding how you understand and experience well-being? At work? In your personal life?

Questions for the Arm 2:

Q area: In the baseline interview, we discussed your understanding and experience of compassion. Can you speak about any changes you’ve noticed in the last 4 months regarding how you understand and experience compassion? At work? In your personal life?
Q area: In the baseline interview, we also discussed your understanding and experience of well-being. Can you speak about any changes you’ve noticed in the last 4 months regarding how you understand and experience well-being? At work? In your personal life?
Timepoint [26] 334555 0
Intervention follow-up (16 weeks after intervention commencement)
Secondary outcome [27] 334563 0
Heart Rate Variability (HRV) will be measured using state-of-the-art non-invasive devices (E4 Empatica wristband: empatica.com), as follows:

1. Participants in all three groups will be asked to wear the wristbands on baseline for six minutes (with eyes closed)
2. Participants will be asked to wear the wristband continuously during the training programs in the two active groups
3. In the mediation arm of the trial, participants will be asked to indicate the beginning and ending of meditation periods by pressing a button on the device.
4. Participants will be asked to wear the wristbands for six minutes (with eyes closed) at the conclusion of day three of training (active groups only)
Timepoint [27] 334563 0
Timepoint: HRV wrisbands will be worn at baseline (immediately before Workshop 1 commences) and at week 4 post-intervention)

Eligibility
Key inclusion criteria
Participants must be employees of NSW Health
Participants must be nurses or midwives
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nurses or midwives who are currently on leave related to stress or illness
Nurses or midwives who are working less than the equivalent of three days per week on average

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a piece of random number generating software – ‘Research Randomiser’.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
We are randomising clinical units not individuals, so this is a cluster randomised trial (CRT).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A statistical power calculation based on the primary outcomes of interest was conducted. This sample size calculation suggests that a sample size of 80 in each group provides an 80% power of detecting a difference of 0.5 points or more at the P < 0.05 significance level.

After the completion of data collection, the quantitative data will be entered and analysed using statistical software (SPSS and MPlus) at The Australian Catholic University and The University of Sydney. For example, looking at the differences between groups (two different interventions (Sankalpa and Epicorma) and the waitlist group using ANOVA and looking for patterns in the data for how these effects occur using Multiple Regression or Hierarchical Linear Modelling.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/05/2017
Actual
Date of last participant enrolment
Anticipated
31/08/2017
Actual
Date of last data collection
Anticipated
31/01/2018
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7832 0
Balmain Hospital - Balmain
Recruitment hospital [2] 7833 0
Canterbury Hospital - Campsie
Recruitment hospital [3] 7834 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 7835 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 15770 0
2041 - Balmain
Recruitment postcode(s) [2] 15771 0
2194 - Campsie
Recruitment postcode(s) [3] 15772 0
2139 - Concord
Recruitment postcode(s) [4] 15773 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 295960 0
Charities/Societies/Foundations
Name [1] 295960 0
John Templeton Foundation: Happiness and Wellbeing Project
Country [1] 295960 0
United States of America
Primary sponsor type
University
Name
Australian Catholic University
Address
Institute for Positive Psychology & Education
Australian Catholic University
25A Barker Road
Strathfield NSW 2135 Australia
Country
Australia
Secondary sponsor category [1] 295096 0
Government body
Name [1] 295096 0
NSW Department of Health
Address [1] 295096 0
Level 11, KGV Bldg
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW, 2050
Country [1] 295096 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297231 0
Research Ethics and Governance Office, Sydney Local Health District, NSW Department of Health
Ethics committee address [1] 297231 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Ethics committee country [1] 297231 0
Australia
Date submitted for ethics approval [1] 297231 0
27/09/2016
Approval date [1] 297231 0
22/02/2017
Ethics approval number [1] 297231 0
X16-0413 & HREC/16/RPAH/583

Summary
Brief summary
This RCT compares two interventions designed to enhance nurse well-being and compassion with a control group. Nursing teams will be randomized into one of three conditions: a) a meditation training program, b) a positive psychology training program and c) a wait list control group. Pre-, post- and 4-month follow-up self-report measures of nurse well-being, compassionate care and related measures will be administered along with physiological measures of nurse heart-rate variability. In addition, ethnographic interviews and ethnographic observations will be undertaken along with semi-structured interviews with nurses regarding their experiences of compassionate care, Lastly, the study will explore the effects of the interventions on compassionate care among nurse-patient dyads and among nurses' broader social networks.
Trial website
http://www.happinessandwellbeing.org/huppert/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73398 0
Dr Paul Atkins
Address 73398 0
Institute for Positive Psychology & Education
Australian Catholic University
25A Barker Road
Strathfield NSW 2135 Australia
Country 73398 0
Australia
Phone 73398 0
+61 2 9701 4626
Fax 73398 0
Email 73398 0
[email protected]
Contact person for public queries
Name 73399 0
Dr Paul Atkins
Address 73399 0
Institute for Positive Psychology & Education
Australian Catholic University
25A Barker Road
Strathfield NSW 2135 Australia
Country 73399 0
Australia
Phone 73399 0
+61 2 9701 4626
Fax 73399 0
Email 73399 0
[email protected]
Contact person for scientific queries
Name 73400 0
Dr Paul Atkins
Address 73400 0
Institute for Positive Psychology & Education
Australian Catholic University
25A Barker Road
Strathfield NSW 2135 Australia
Country 73400 0
Australia
Phone 73400 0
+61 2 9701 4626
Fax 73400 0
Email 73400 0
[email protected]

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No Supporting Document Provided



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